The Many Gray Areas Of Biosimilar Commercialization
The Many Gray Areas Of Biosimilar Commercialization

Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.

  • Changes In Regulatory Requirements For Biosimilar Development In India
    Changes In Regulatory Requirements For Biosimilar Development In India

    In August 2016, India’s Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology revised the September 2012 Guideline for Similar Biologics. The revision was done to keep pace with ever changing global standards and to streamline the regulatory process for the authorization of biosimilars in India. What do biosimilar makers need to know?

  • Trump And The FDA: What to Expect (And What’s At Stake)
    Trump And The FDA: What to Expect (And What’s At Stake)

    Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.

  • How To Approach U.S. Physicians About Biosimilars
    How To Approach U.S. Physicians About Biosimilars

    As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.

  • Serialization Data – Who Needs It And Why?
    Serialization Data – Who Needs It And Why?

    As pharmaceutical manufacturers continue to implement serialization capabilities, there is often a failure to recognize key stakeholders within the organization who will require access to serial number data. For some organizational roles, access to serialization data will be needed on a routine basis to perform on-going activities, while for other roles the need may be required as part of an unplanned event, such as a recall, product complaint, or inquiry. To date, the majority of attention for defining requirements and qualifying solutions has resided with the serialization program/project team and has been concentrated on the data exchange between manufacturer and contract manufacturer enterprise systems and between enterprise systems and packaging site/line systems.

  • Comparing Recent Data Management/Integrity Guidances: FDA, EMA, & China FDA
    Comparing Recent Data Management/Integrity Guidances: FDA, EMA, & China FDA

    In 2015 and 2016, six major international regulatory authorities published guidance documents addressing data management and data integrity. Two of the guidances — the draft guidance published by the U.S. Food and Drug Administration (FDA) in April 2016 and the guidance posted by the European Medicines Agency (EMA) in August 2016, take a question and answer approach.

  • How To Make The Most Of Your FDA Biosimilar Meetings
    How To Make The Most Of Your FDA Biosimilar Meetings

    The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.

  • Do You Make This Critical Root Cause Analysis (RCA) Mistake?
    Do You Make This Critical Root Cause Analysis (RCA) Mistake?

    In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.

  • Aseptic Processing Risk Management — Challenges & Common Misconceptions
    Aseptic Processing Risk Management — Challenges & Common Misconceptions

    Once a process is identified as “risky,” we tend to accept that risk and do little to try to uncover ways to reduce that risk and improve the process.

  • How These Biosimilar Unknowns Could Impact Manufacturers
    How These Biosimilar Unknowns Could Impact Manufacturers

    During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

  • Simplifying Recombinant Protein Production: Breaking Down The Corynex® Protein Expression System

    Pharmaceutical companies looking to take a piece of the biologics pie must come up with innovative ways to approach drug development and cut the high costs associated with it. One way to do this is to simplify the processes to produce and purify recombinant proteins. Yasuhiro Takenaka, senior director of technical development at Althea, explains how the Corynex® Protein Expression System uses an extensive toolbox to improve the levels of protein secretion and overall success rate.

  • Segmentation Of The Diagnostics Market

    The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.

  • What A Successful CMO For Diagnostic Consumables Looks Like

    The intricacy of emerging diagnostic consumables necessitates manufacturing competencies that span a wide range of disciplines. As diagnostic companies continue to develop complex consumables, the need for a strong relationship with a consumable diagnostics CMO specializing in everything from early product design to final product manufacturing will become increasingly more important.

  • Microfluidic Point Of Care Devices

    Microfluidic Point-of-Care device technology is intersecting multiple disciplines such as materials science, systems engineering, physics, chemistry and biology. The design and manufacturing of such products require a comprehensive array of abilities, and these technologies funneled into compact devices offer an exciting foundation for innovation.

  • CLIA – Clinical Laboratory Improvement Amendments

    Developers of diagnostics devices are faced with the ever-increasing challenge of balancing the drive to create technologically advanced products with the pressures of today’s thrifty healthcare consumers. During the innovation process, the question often arises as to what level of regulation a diagnostic product needs to be designed, manufactured, and tested to. This article provides a brief overview of the requirements and considerations for the clinical diagnostic innovations.

More From Biosimilar...

TRAINING COURSES

The Future Of Outsourcing In Clinical Research – Preparing For A Changing Global Landscape December 7, 2016
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Update to ICH GCP E6 (R2) – Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Identification of Medicinal Products (IDMP) – Building a Compliance-Driven Pilot Program December 13, 2016
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations December 14, 2016
10:30am-12pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Responding Effectively To FDA Form 483 Observations - Strategies To Ensure Compliance December 15, 2016
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Upcoming Courses
Anna Rose Welch article header

ARCHIVES

ABOUT BIOSIMILAR DEVELOPMENT

Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.

Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.